Trasylol Class Action Lawsuit
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by: Steve Fields94
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There are estimates that at least 10,000 patients may unnecessarily have suffered kidney problems including kidney failure due to use of aprotinin during heart surgery. Many patients throughout the United States may have been injected with Trasylol to reduce blood loss during coronary artery bypass (CABG) surgery.
The Food and Drug Administration approved Aprotinin in 1993, a drug marketed by Bayer as Trasylol. Sales of Trasylol over the past several years have escalated to more than $600 million.
Most patients and families of loved ones undergoing heart surgery are largely unaware if Trasylol was used during their heart surgery. The decision to use aprotinin (Trasylol) was made by a patient’s treating doctor.
Aprotinin (Trasylol) affects the way in which blood clots. Trasylol is injected into patients who are undergoing open heart surgery. Excessive bleeding, during and after heart surgery, is a serious complication. Such bleeding exposes patients to multiple risks. Trasylol is primarily used during repeat coronary artery bypass surgery to reduce the amount of bleeding. The amount of blood transfusion required is reduced by using clotting medications including Trasylol.
A recent study, published by the New England Journal of Medicine (NEJM) (2006) reported a connection between Trasylol and increased risk of renal (kidney) failure, myocardial infarction, heart failure or stroke in patients who have had heart surgery. The NEJM study concluded that two other generic drugs were available that were safer and less expensive than Trasylol.
1 Amicar cost per dose is $11
2 Cyklokapron cost per dose is $44
3 Trasylol cost per dose is $1300.
Neither of the generic drugs was associated with increased risk of kidney failure, heart attack or stroke.
The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drug Advisory Committee met on September 21, 2006 to review recent data regarding the safety of aprotinin. On September 29, 2006, the FDA issued a public health advisory stating that it had learned Bayer failed to disclose a study that Bayer had conducted involving 67,000 patients undergoing heart surgery. Preliminary analysis of the Bayer study suggested that Trasylol use was linked with risk for congestive heart failure, kidney disease, stoke and death. Bayer did not disclose the study during the September 21, 2006 Advisory Committee meeting.
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Steve Fields is author of this article on Trasylol kidney failure attorneys. Find more information about Trasylol heart surgery lawsuit attorney here.
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